Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study
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|ClinicalTrials.gov Identifier: NCT03228485|
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment|
|Prostatic Hyperplasia Lower Urinary Tract Symptoms||Device: MyBPH Care mobile app|
One of the next developments in healthcare is digitalization, including (mobile) applications that could support healthcare providers. A significant number of aging men suffer from lower urinary tract symptoms (LUTS), often caused by benign prostate hyperplasia (BPH). LUTS/BPH is primarily treated by physicians (GPs or Urologists). Optimal evaluation of patients with LUTS/BPH, treatment selection and follow-up by the physicians and medication adherence are essential in the management of LUTS. This pilot project represents a strong collaboration between a urological association, urologists, and physicians in supporting healthcare improvement for LUTS/BPH with the use of a (mobile) application. The hypothesis is that the (mobile) application can support the patient in medication adherence and improve the adherence by feedback and that the application can help to collect objective disease information with electronic questionnaires.
The primary objective is to assess the feasibility, and acceptability of a (mobile) application for men presenting at their physician's office with LUTS/BPH; starting with medical therapy and naïve for treatment.
The secondary objectives are to identify potential gaps, clarify controversial points of the application, to document the communication between patients, physicians and supervising urologists in order to optimize (if necessary) the application, to assess medication adherence and to record if treatment provided by physicians is in compliance with the guidelines recommendations.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||The Feasibility and Acceptability of a (Mobile) Application for Men With LUTS/BPH: a Pilot Study|
|Actual Study Start Date :||April 4, 2019|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||April 10, 2020|
All patients enrolled in this study.
Device: MyBPH Care mobile app
The application that will give daily medication reminders and via which the questionnaires can be filled out.
- Feasibility of a mobile application for LUTS [ Time Frame: 6 months ]The feasibility is assessed by the application use of patients. The patients application will be judged as Definitely Feasible if the study is completed for ≥70% eligible patients, Possibly Feasible (completed for 50-69% eligible patients) or Not Feasible (completed for <50%).
- Acceptability and satisfaction of a mobile application for LUTS [ Time Frame: 6 months ]In order to assess the acceptance and satisfaction of the mobile application including the application subjective quality and perceived impact, a questionnaire will be used. This questionnaire is based on a standardized application rating questionnaire, namely the user Mobile Application Rating Scale (uMARS). Outcomes are described and compared between centers.
- Medication adherence [ Time Frame: 6 months ]Self-reported medication adherence by the patient via the application over the full period of the pilot.
- Compliance to guidelines [ Time Frame: At baseline ]Descriptive comparison between the medication prescribed by the physician and the advised medication according to the international guidelines based on the patient characteristics.
- Referral network [ Time Frame: At the end of the 6 months period ]Evaluation of the referral communication between the physicians and the supervising urologist by questions in the final questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228485
|Contact: Stavros Gravas, MD||+30-2413 firstname.lastname@example.org|
|Contact: Jean de la Rosette, MD, PhDemail@example.com|
|University Hospital of Larissa, Institute for Monitoring of Urogenital Diseases||Recruiting|
|Larissa, Greece, 10|
|Contact: S Gravas, Dr. +30-2413 502983 firstname.lastname@example.org|
|University of Florence||Recruiting|
|Contact: Mauro Gacci, MD email@example.com|
|Hospital de Santo Antonio||Recruiting|
|Contact: Vitor Cavadas, MD firstname.lastname@example.org|
|Hospital Universitario la Zarzuela||Not yet recruiting|
|Madrid, Spain, 28023|
|Contact: Ignacio Moncada Iribarren, Prof. Dr. email@example.com|
|Istanbul Medipol University||Recruiting|
|Contact: Jean J de la Rosette, Prof. dr. firstname.lastname@example.org|
|Contact: Selçuk Guven, MD email@example.com|
|Study Chair:||Stavros Gravas, MD||Societe Internationale d'Urologie|